Effect of Combination of Mitiglinide and Metformin on Glycemic Control in Patients With Type 2 Diabetes Mellitus

NCT01037842 | Completed Phase 3 DMC

• 1 other identifier: IMMEDIATE
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 13

Brief Summary

We performed a prospective, randomized, multicenter trial to assess the efficacy and safety of combined treatment with mitiglinide and metformin for patients with type 2 diabetes who show inadequate glycemic control with metformin monotherapy. Subjects with HbA1c \>7.0% after an 8-week metformin run-in phase were randomized to a 16-week trial phase with metformin plus mitiglinide (Met+Mit) or metformin plus placebo (Met).

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• the change in HbA1c from randomization to endpoint

  16 weeks after radomization

Secondary Outcomes (1)

• the proportion of subjects with HbA1c <7% after 16 weeks of treatment and the change in FPG and 2-hr postprandial glucose (PPG) from baseline

  16 weeks after radomization

Study Arms (2)

Metformin+Mitiglinide

ACTIVE COMPARATOR

mitiglinide 10 mg three times a day added to metformin 500 mg three times a day

Drug: Mitiglinide

Metformin+Placebo

PLACEBO COMPARATOR

placebo three times a day added to metformin 500 mg three times a day

Drug: Placebo

Interventions

Mitiglinide DRUG

mitiglinide 10 mg three times a day added to metformin 500 mg three times a day for 16 weeks

Metformin+Mitiglinide

Placebo DRUG

placebo three times a day added to metformin 500 mg three times a day for 16 weeks

Metformin+Placebo

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 30-70 years
• had a duration of diabetes of \<10 years
• body mass index (BMI) 20-35 kg/m2
• a plasma HbA1c level of 7.5-11% during the previous 4 weeks

You may not qualify if:

• subjects who were diagnosed with type 1 diabetes, gestational diabetes, or diabetes with any specific causes
• Subjects who had been treated with nateglinide, repaglinide, metformin (over 1,000 mg/day), or sulfonylurea (over a quarter of the maximum recommended dose) during the previous 8 weeks

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul St. Mary's Hospital: collaborator
• The Catholic University of Korea: collaborator
• Uijeongbu St. Mary Hospital: collaborator
• Korea University: collaborator
• Kyungpook National University Hospital: collaborator
• Pusan National University College of Medicine: collaborator
• Sungkyunkwan University: collaborator
• Yonsei University: collaborator
• Eulji University: collaborator
• Chonnam National University: collaborator
• Chonbuk National University: collaborator
• Chungnam National University: collaborator
• Hallym University: collaborator

Study Sites (13)

Pusan National University College of Medicine

Busan, South Korea

Location

Kyungpook National University School of Medicine

Daegu, South Korea

Location

Chungnam National University College of Medicine

Daejeon, South Korea

Location

Chonnam National University College of Medicine

Gwangju, South Korea

Location

Chonbuk National University College of Medicine

Jeonju, South Korea

Location

Eulji University School of Medicine

Seoul, South Korea

Location

Hallym University College of Medicine

Seoul, South Korea

Location

Korea University College of Medicine

Seoul, South Korea

Location

Seoul St. Mary's Hospital

Seoul, South Korea

Location

SungKyunKwan University School of Medicine

Seoul, South Korea

Location

The Catholic University of Korea

Seoul, South Korea

Location

Yonsei University College of Medicine

Seoul, South Korea

Location

Uijeongbu St. Mary Hospital

Uijeongbu-si, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

mitiglinide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 19, 2009
• First Posted: December 23, 2009
• Study Start: August 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: May 1, 2008
• Last Updated: December 23, 2009

Record last verified: 2009-12

Locations

KR (13)